A Randomized Trial of Thymoglobulin to Prevent Chronic Graft Versus Host Disease in Patients Undergoing Hematopoietic Progenitor Cell Transplantation (HPCT) From Unrelated Donors
16 Years
70 Years
Both
Hematologic Malignancies
Trial Information
A Randomized Trial of Thymoglobulin to Prevent Chronic Graft Versus Host Disease in Patients Undergoing Hematopoietic Progenitor Cell Transplantation (HPCT) From Unrelated Donors
This study is a non-blinded, randomized, multicentre trial testing the effect of
Thymoglobulin® vs. placebo on the primary outcome of cGVHD. Subjects will be children and
adults having unrelated donor transplants.
Intervention: Infusion of Thymoglobulin® on three days prior to the transplant.
Hypothesis: The hypothesis is that the use of Thymoglobulin® in the experimental group will
result in an absolute 20% increase in the number of patients free of cGVHD at 12 months, the
time of peak incidence, from 20% in the control group to 40% in the experimental group.
Outcome Measures: The Primary Outcome Measure is freedom from cGVHD at 12 months from
transplantation, defined as withdrawal of all systemic immunosuppressive agents and without
resumption up to 12 months (a binary end-point, yes/no). Secondary outcome measures:
Quality of Life, overall incidence of cGVHD (including untreated cases and resolved cases),
the incidence of "extensive" cGVHD, time to non-relapse mortality, time to all-cause
mortality, time to relapse of leukemia, graft rejection or failure (Yes vs. No), serious
infection (Yes vs. No), CMV activation (Yes vs. No), organ-specific grading of chronic graft
versus host disease, resumption of immunosuppressive agents after 12 months (Yes vs. No),
doses of immunosuppressive drugs still required at 12 months, and incidence of acute graft
versus host disease.
Inclusion Criteria:
- The recipient has a hematologic malignancy
- The recipient will receive one of the specified preparative regimens
- The recipient will receive either a bone marrow ("HPC, Marrow") or blood
progenitor cell ("HPC, Apheresis") graft
- The recipient has an unrelated donor who with high resolution typing is either fully
MHC matched at HLA-A, B, C and DRB1 with the recipient or is 1-antigen or 1-allele
mismatched at A, B, C or DRB1 loci The recipient meets the transplant centre's
criteria for unrelated donor allogeneic transplantation , either myeloablative or
non-myeloablative (syn. RIC).
- The recipient has good performance status (Karnofsky ≥60%)
- Recipient has given signed informed consent For the questionnaire component only, be
able to complete the questionnaires in English or with a validated translation (as
posted on the project website)
Exclusion Criteria:
- The recipient is HIV antibody positive
- The recipient has a hypersensitivity to rabbit proteins or Thymoglobulin
pharmaceutical excipients, glycine or mannitol
- The recipient has active or chronic infection (i.e. infection requiring oral or IV
therapy)
- The recipient (if female and of childbearing potential) is pregnant or breast-feeding
at the time of enrollment
- The recipient (if female and of childbearing potential) does not agree to use an
adequate contraceptive method from the time of enrollment until a minimum of one year
following transplant
- The recipient (if male and fertile) does not agree to use an adequate contraceptive
method from the time of enrollment until a minimum of one year following transplant
- For the questionnaire component only, the recipient is unable to participate due to
cognitive, linguistic or emotional difficulties (i.e. the recipient can participate
in the main study but will be excluded from the questionnaire component
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Freedom from Chronic GVHD
Outcome Description:
"Freedom from Chronic GVHD" is defined as withdrawal of all systemic immunosuppressive agents and without resumption up to 12 months (a binary endpoint, yes/no)
Outcome Time Frame:
12 months post transplant
Safety Issue:
No
Principal Investigator
Irwin Walker, MD
Investigator Role:
Study Chair
Investigator Affiliation:
McMaster University, Faculty of Health Sciences
Authority:
Canada: Health Canada
Study ID:
CBMTG 0801
NCT ID:
NCT01217723
Start Date:
April 2010
Completion Date:
January 2014
Related Keywords:
- Hematologic Malignancies
- Acute leukemia (myeloid,lymphoid,or biphenotypic)
- Chronic myeloid leukemia
- Chronic lymphocytic leukemia
- Lymphoma
- Myelodysplastic syndrome
- Myeloproliferative disorder
- Neoplasms
- Graft vs Host Disease
- Hematologic Neoplasms
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